MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device was discarded.A follow-up report will be submitted with all additional relevant information.The mitraclip ntr referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the steerable guide catheter soft tip tear.It was reported the mitraclip procedure was performed to treat degenerative mitral regurgitation (mr), with an mr grade of 4.The steerable guide catheter (sgc) and mitraclip delivery system (cds) were advanced.During the straddling step, the user did a check by moving the cds to confirm the distance of the atrium lateral wall.Grasping the leaflets was challenging and during grasping attempts the grippers arms stayed in the down position, independently of the gripper lever position.Additionally, the clip did not fully close further than 45 degrees.The clip was not implanted and the cds was retracted but got caught on the sgc soft tip.The sgc soft tip was damaged.Both devices were removed.Once the cds was outside of the anatomy, it was observed that the gripper arms did not look symmetric with the clip arms.When the clip was out, the physician closed the clip arm by hand, a "click" sound was heard and then the clip arm managed to be fully closed.At each sequence to open to close, the clip arm looked slightly blocked at 45 degree and managed to close finally.It cannot be determined if the clip damage occurred during movement of the cds during straddling or during removal of the cds.A new sgc was used and two clips were implanted without issue, reducing mr to 1-2.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and the reported torn, split or cut material (soft tip tear) appears to be related to the procedural conditions of the clip becoming caught on the sgc soft tip.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the cds was curved approximately 100 degrees during positioning.An attempt was made to test removability of the gripper line to confirm the gripper line was not blocking the clip arms.However, resistance was felt after the gripper line was retracted 20cm.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11052703
• MDR Text Key: 223137811
• Report Number: 2024168-2020-10824
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00803U208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP DELIVERY SYSTEM.; MITRACLIP DELIVERY SYSTEM